COVID-19 Vaccine – A Powerful Tool in our Public Health Arsenal

Vaccines are one of the most cost-effective and successful interventions against infections invented to keep people healthy. Our body has elaborate mechanisms to fight off infections caused by pathogens. These mechanisms, collectively known as our immune systems, “remember” how they fought off prior pathogens and remain ready for future infection. A vaccine may contain parts of the pathogen, killed whole pathogen or genetic materials from the pathogen. Several vaccines for Corona Virus Infectious Disease 2019 (COVID-19) are being developed using genetic material from the Severe Acute Respiratory Syndrome-2 (SARS-2) virus that causes COVID-19.

Vaccines at Work

Vaccination teaches/stimulates our immune system (immune response) and builds immune memory without causing the infection. We develop antibodies, and other defense molecules via activation of white blood cells through vaccination which then neutralize the pathogen upon infection and in most cases, prevent illness. The threat of infection is reduced when a significant majority of the population are vaccinated to develop “herd immunity”, thus reducing the ability of the infection to spread in the community.

Development of COVID-19 Vaccine

As Phase 3 clinical trials of COVID-19 vaccine candidates are underway this fall, questions are raised about the development, safety and approval process of vaccines. Vaccine development is often a very long and daunting process that takes about 10 years on average from beginning to end. It requires scientists to find the right formulation that would trigger a robust, yet safe immune response. This careful process of vaccine development and approval is necessary to ensure public safety.

Once a candidate vaccine has been identified, it goes through a rigorous process of testing in human volunteers known as clinical trials. Clinical trials must be long enough to show not only that there is an adequate immune response that protects the individual, but also that immunity is long-lasting, and is safe. Typically, the efficacy and safety of the vaccine are studied in thousands of human volunteers in phase 3 clinical trials with oversight from the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER).  CBER reviews clinical trial data to do a risk/ benefit assessment to recommend or oppose the approval of a vaccine. A non-FDA expert committee on Vaccines and Related Biological Products Advisory Committee (VRBPAC, a panel of scientists, physicians, biostatisticians, and a consumer representative) also reviews the findings and advice of CBER regarding safety, efficacy, benefits and risks of the vaccine. Only with proper recommendation (from CBER and VRBPAC) will a new vaccine be released to the public. According to FDA criteria, at least half of vaccinated individuals must be protected in order for a COVID-19 vaccine to be considered effective.

Even after release of a vaccine, the Centers for Disease Control and Prevention (CDC) will continue to monitor and oversee the vaccine safety using the Vaccine Adverse Event Reporting System (VARES).

Trial Phase

Although vaccines are drugs, their development is fundamentally different than a traditional drug. Vaccine clinical trials are done in non-infected, healthy subjects to determine immune response, but a drug clinical trial recruits patients with the disease to test its efficacy.

COVID-19 vaccines are being developed on a “fast-track” basis, and currently ~over 240 different vaccine candidates are in various stages of development worldwide. Of these, roughly ten formulations are the front runners and have advanced to Phase 3 trials in human volunteers. The majority of these formulations are based on the genetic material of the Coronavirus, ribonucleic acid (RNA), and would require two doses approximately three weeks apart.

Production and Release

Due to the urgent need for a COVID-19 vaccine, some vaccines are already being produced in large scale concurrently as we await final approval and Emergency Use Authorizations (EUAs) decisions by CBER. Therefore, once approved, the/se vaccine/s will be quickly distributed to the public following the CDC guidance and priority list. Although difficult to predict, the most optimistic timeline for release of the first batch of COVID-19 vaccines is within the next several months. The “fast track” approved vaccine/s will be administered to people following a “framework for equitable allocation”. Most experts think that a vaccine is likely to become widely available by mid-2021. While the race towards the vaccine continues to the finish line, “vaccine hesitancy” in certain U. S. populations could be a barrier to defeating the pandemic. Building public trust and confidence in COVID-19 B vaccine is necessary to win over the pandemic.

Article by Dr. Manas Mandal, MSc, PhD

About Manas Mandal, PhD

Dr. Manas MandalDr. Mandal specializes in teaching, and research in immunology. He earned his Bachelor of Science and Master of Science degrees in Human Physiology from the Calcutta University, India and his Doctor of Philosophy in Science from the Jadavpur University, Calcutta. He completed post-doctoral trainings in cellular immunology at the Gwen Knapp Center for Lupus and Immunology Research, University of Chicago, and in vaccine delivery at the University of Michigan, College of Pharmacy. Dr. Mandal held research faculty positions at the University of Michigan, and Virginia Tech. At Virginia Tech, he was involved in bio-defense research in Tularemia. Currently, he is an Associate Professor of Pharmaceutical Sciences at the Roseman University College of Pharmacy where he teaches courses in Hematology & Immunology.

Dr. Mandal has presented his research at national and international scientific meetings in pharmaceutical sciences, immunology, and pharmacy education. He has served the American Association of Colleges of Pharmacy (AACP), National Association of Boards of Pharmacy (NABP), Accreditation Council of Pharmacy Education (ACPE) and American Association of Pharmaceutical Scientists (AAPS) in various capacities serving on committees, reviewing grants, abstracts, judging posters, writing items and performing accreditation site visits.

Dr. Mandal was awarded a Fulbright Specialist appointment with the US Department of State’s Bureau of Education and Cultural Affairs (ECA) and World Learning in 2019 with a three-year tenure. He also served as an editor for the Microbial Toxins in Handbook of Toxinology, Springer in 2015-2017, and contributed a chapter. His current research interest includes salivary biomarkers, anti-inflammatory properties of natural products, and student knowledge retention. Dr. Mandal is a member of the AACP, AAPS, and American Association of Immunologists (AAI) & American Association of Advancement of Science (AAAS).

Featured Physician – Dr. David Ginsburg

Neurologist Breaking Barriers in Patient-Centered Care

Dr. David Ginsburg, a practicing Neurologist at Roseman Medical Group, specializes in the diagnosis and treatment of the nervous system and neurological disorders. A Doctor of Medicine degree from the University of Pittsburgh and a residency in neurology at Los Angeles County-USC Medical Center are just two of the credentials which guided and helped Dr. Ginsburg find his passion for helping patients with neurological disorders.

Always having an interest in circuits and gadgets, it is easy to see why neurology – somewhat an extension of those concepts involving the human body – made complete sense to Dr. Ginsburg. Other guiding factors in his pursuit for helping patients with neurological disorders were the realization of untapped knowledge within the field of neurology, the large gaps in patient care, and experiencing his own family members’ dementia diagnoses. In acknowledging these factors, Dr. Ginsburg is breaking barriers in patient-centered care through caring for the whole patient, using innovative practices for early and accurate diagnoses, and continuing to be an advocate for the many neurologic disorders – such as ALS (amyotrophic lateral sclerosis or Lou Gehrig’s disease).

ALS Explained

ALS (amyotrophic lateral sclerosis) is a progressive neurodegenerative disease affecting the nerve cells in the brain and spinal cord. The disease characteristically involves a gradual onset. The symptoms can vary amongst individuals, although advanced muscle weakness and paralysis are commonly experienced. These commonly experienced symptoms can make everyday tasks very difficult – such as grasping objects or even walking.

The ALS Association states that over 5,000 people are diagnosed every year with someone being diagnosed or passing away from ALS every 90 minutes. Receiving a diagnosis is challenging and overwhelming for both the patient and their caregiver. While there is not yet a cure or treatment for the disease, there are countless amounts of collective knowledge and wisdom available from health care providers, such as Dr. David Ginsburg and his team.

Patient-Centered Care – Breaking Down Barriers

The first challenge for a patient is an early and accurate diagnosis. The second challenge is receiving the proper treatment in a timely fashion. Dr. Ginsburg has met these challenges head-on by utilizing our EMG Laboratory to make early and accurate diagnoses and spearheading the monthly ALS clinic to create ease of access to specialist for ALS patients.

Electromyography (EMG) Laboratory

Electromyography is a type of diagnostic test used to evaluate the body’s nerve and muscle function. It allows for more accurate diagnoses for improved treatment and outcomes. Dr. Ginsburg gained extensive background in neurodiagnostic testing with EMG during his residency in neurology and fellowship in clinical neurophysiology. Today, with his team of professionals, he utilizes this tool to provide real-time diagnosis to patients while providing the highest quality of healthcare. Because of these efforts, Dr. Ginsburg achieved “Exemplary Status” by the American Associate of Neuromuscular and Electrodiagnostic Medicine (AANEM). This accreditation status, as well as his achievement of the first accredited EMG lab within the state of Nevada while working at the UNR School of Medicine in 2012, reflects the dedication of Dr. Ginsburg’s work in caring for his neurology patients.

Monthly ALS Clinic

Compassionate care in a supportive atmosphere and ease of access to specialists are top of mind for Dr. Ginsburg and his patients. Through the multidisciplinary ALS Clinic, Dr. Ginsburg and a team of highly qualified healthcare professionals work together to address the needs of individuals living with ALS. Dr. Ginsburg states, “Although the Clinic is unable to reverse the disease course, the multidisciplinary approach allows them to provide patients with the highest level of care currently available to address their multiple needs.” The clinic provides care to six patients during each monthly half-day clinic in which each patient spends about three hours receiving care from a variety of specialists based on their individual needs. During a given clinic visit a patient can expect to receive access to a speech therapist, occupational and physical therapist, respiratory therapist, dietitians, nursing/social services, and others to assist them in living with the disease. The Clinic helps in eliminating the time and cost associated with having to visit multiple clinics for numerous appointments with various specialists, streamlining care and allowing for treatment of the whole patient.

Defeating ALS

While there is not yet a cure or treatment that stops ALS, continued research and support to find a cure is ongoing. Dr. Ginsburg continues to be an advocate for his patients and their families. Through his continued involvement with pharmaceutical industry-sponsored trials with new medications to participating in the Annual Walk to Defeat ALS, Dr. Ginsburg meticulously works to assist ALS patients through their medical journey while supporting efforts for advanced research.

Receiving a diagnosis and getting the proper treatment and care doesn’t have to be a challenge. Patients with ALS, and their families face enough challenges with the relentless progression of disability. With innovative tools and a drive to provide a positive patient experience, Dr. Ginsburg continues to break barriers in patient-centered care. Dr. Ginsburg’s approach to providing the highest quality healthcare to his patients can be summed up by this thought, “We see patients in their most vulnerable state, and knowing that we provide the best possible care provides patients with a sense of comfort and confidence that we are always available to support their needs. This in turn provides me with a great sense of accomplishment and satisfaction knowing that patients’ needs are being met to the greatest extent possible.”

Please visit the ALS Association at als.org for more information on ALS, also known as Lou Gehrig’s disease.

Help Dr. Ginsburg and the Roseman Medical Group defeat ALS by visiting web.alsa.org/goto/roseman as we Walk to Defeat ALS “virtually” on Sunday, November 8.

Article by Kristine Campo

Halloween and COVID-19 – No Need to be Frightened

Witch, dinosaur, clown, or princess – just one of the many decisions as families navigate Halloween during the COVID-19 pandemic. Costumes, pumpkin decorating, and trick-or-treating are traditions almost every child looks forward to during Halloween. A holiday focused on community and neighborly get-togethers since the 1800s, Halloween doesn’t have to be a challenge in 2020. Although it’s recommended to avoid large gatherings and keep a distance of six feet from others, there are still plenty of ways families can have fun and stay safe this Halloween.

Costumes

Selecting a costume not only brings a child’s imagination to life, it’s something they look forward to every year. The CDC states that costume masks should not be a substitute for a cloth mask, and they should not be worn over cloth masks as it can make breathing difficult. Don’t let a cloth face covering stand in the way. Think outside the box and incorporate the face covering as a part of the costume. Painted whiskers on a black face covering for a kitten or ferocious dinosaur teeth on a green face covering – unleash that creativity.

Selecting the costume is just half the fun. When it comes time to show it off, instead of the traditional costume party opt for a virtual party with family and friends or an outdoor costume parade with neighbors – staying at least 6 feet apart of course.

Decorating Pumpkins

Carving, painting, drawing – all fun ways to turn a pumpkin into a jack-o’-lantern. This safe and fun activity can be done at home away from large gatherings. If carving, children can draw a fun face with a marker and parents can do the cutting to avoid injuries. Painting and drawing are also a great alternative and give children the opportunity to let their imagination and creativity run wild! Don’t forget, all those pumpkin seeds make a healthy snack when roasted.

Trick-or-treating

Going door-to-door in the neighborhood may be discouraged in some areas this year, but there are alternatives in keeping this tradition safe and fun. One alternative to consider is a spooky family scavenger hunt for Halloween treats in the house or yard. Consider hiding candy, glow sticks, stickers, and more. If trick-or-treating in the neighborhood, be sure to stay at least six feet away from others and avoid gathering at doorsteps with other trick-or-treaters.

Planning to hand-out treats in the neighborhood? The possibilities are endless to avoid direct contact with trick-or-treaters. Consider individually prepackaged goodies presented in an area where children can easily access them, such as a table by the curb where children can grab and go. Some families are creating chutes out of old shipping tubes, while others are creating flying ghosts on a zip line. Regardless of the method, it’s best to preserve distance and keep those hands clean.

As Halloween night ends and the thought of dumping all the candy out and digging in comes to mind, take precautions to keep little ones safe. A good rule of thumb after collecting treats in the neighborhood is to wipe down the packages or let them sit for a couple days before handing them over to the children or sneaking one for yourself!

Costumes, Pumpkins, and Treats - Oh My!

Don’t be frightened by Halloween during the COVID-19 pandemic. This is a time for creativity and the chance to form new, exciting traditions. Create a fun cloth mask that’s part of a costume, utilize all the art supplies to create a spooky jack-o’-lantern, or build a flying ghost that delivers candy to the neighborhood children. Whatever you decide to do this year for Halloween, celebrate safely and enjoy creating magical memories.

More importantly, be sure to follow state and local guidelines, as well as the Center for Disease Control and Prevention recommendations.

Article by Kristine Campo

Breast Cancer Awareness Month

Breast Cancer is the most common cancer among women worldwide according to the World Health Organization and 1 in 8 women in the United States will develop breast cancer in her lifetime. Although it is the most common cancer in women, no one knows the exact causes of breast cancer and doctors rarely know why one woman gets breast cancer over another.

The National Breast Cancer Foundation states “Cancer grows when a cell’s DNA is damaged, but why or how that DNA becomes damaged is still unknown. It could be genetic or environmental, or in most cases, a combination of the two.”

Factors of Breast Cancer

Genetic factors can include gender, age, race, family history, personal health history, menstrual and reproductive history, certain genome changes and dense breast tissue.

Environmental and lifestyle risk factors can include lack of physical activity – sedentary lifestyle, poor diet, being overweight or obese, drinking alcohol, radiation to the chest and combined hormone replacement therapy (HRT).

Even though the exact causes of breast cancer are unknown, preventative measures can be taken. Early detection is key! According to the American Cancer Society, when breast cancer is detected early, and is in the localized stage, the 5-year relative survival rate is 99%.

Monthly Self-Exam

It is recommended that adult women should do a self-exam monthly. According to Johns Hopkins Medical center, “Forty percent of diagnosed breast cancers are detected by women who feel a lump, so establishing a regular breast self-exam is very important.” By performing a monthly self-exam you are familiarizing yourself with how your breasts look and feel so when there is a change, you can tell your healthcare provider.

Clinical Breast Exam

This exam is completed by either your family physician or gynecologist during your annual exam. Your doctor is trained to recognize different types of abnormalities and warning signs of breast cancer. They will do a visual check of skin and tissue and then check your entire breast, underarm and collarbone area for any lumps or abnormalities.

Mammogram

According to National Breast Cancer Foundation “Mammograms can often show a breast lump before it can be felt. They also can show tiny clusters of calcium called micro-calcifications.” It is recommended that women 40 and older should have a mammogram every 1 to 2 years. If you are under 40 but have risk factors associated with breast cancer, ask your healthcare provider about whether mammograms are advisable and how often you should get one.

Live Healthier

In addition to doing monthly self-exams, clinical breast exams and mammograms, living a healthier life can help reduce your risk of breast cancer. Cancer cannot be prevented, but some habits can assist in reducing your risk which include maintaining a healthy weight, staying physically active, eating fruits and vegetables, not smoking, and limiting alcohol consumption.

Let us work ToGetHer to make sure every woman has access to education, screening, treatment, support, and hope, regardless of circumstances. To learn more about breast cancer visit the National Breast Cancer Foundation and don’t forget to schedule your Well Woman Exam today with Roseman Medical Group online or call (702)-463-4040.

Article by Rachael Thomas

Welcome – October Health Monthly

Welcome patients, friends and family of the Roseman Medical Group!

We welcome you to our first clinic newsletter. With this newsletter we hope to keep you informed of news in the clinic as well as provide information and articles on healthcare topics that are important to you.

I am Andra Prum, D.O., and I am the Medical Director of the Roseman Medical Group (RMG) clinic.

As you may know, RMG is affiliated with Roseman University of Health Sciences, and as an academic health practice, we bring to you patient-centered, evidence-based medicine and board-certified primary care and specialty physicians. As part of a University, we teach future healthcare professionals and our affiliation also brings innovation and breakthrough research in medical advances to our community and patients.

RMG is like a family. We are a relatively small practice, and our patients report very high satisfaction scores from their experiences here. It is important to us that you have a comfortable, respectful, positive experience just as much as you deserve high-quality care.  We are here to serve your primary care needs and offer many services that you might not know about including well checks, flu shots, sports physicals, behavioral healthcare, Women’s and Men’s Healthcare including annual pap smears, breast exams, etc., as well as specialized Neurology care treating patients with neuropathies, Movement Disorders, Parkinson’s, and ALS.

COVID-19 turned our world upside down, but we continue to provide high-quality care through telemedicine and in-person appointments. While Nevada is seeing its case count decline, winter will soon be upon us and flu season is right around the corner. We hope you will make your appointment to come in and get your flu shot, as this year it is even more important to do so. We also know that these times may cause more anxiety and stress. These are important things to bring up to your physician, as we are here to take care of the whole person.

We hope that in these times, you practice good self-care by getting rest, proper nutrition and exercise, and find ways to connect with loved ones and friends even if by phone or six feet apart. Connection is vitally important to our happiness and well-being.

On behalf of all the providers at RMG, we welcome you and look forward to caring for you and your family. Together, we will be healthy and Roseman Strong!

October Health Monthly Articles

Roseman Medical Group’s Dr. Tom Hunt Offers Insight on Telemedicine

The COVID-19 pandemic has forced our society to make dramatic changes in how we live. This includes routine visits with healthcare providers. Dr. Tom Hunt, a family medicine physician at Roseman Medical Group, recently discussed the rise virtual health with the Las Vegas Sun. He shared how the benefits and uses of telehealth need to be incorporated into residency training for our new generation of physicians completing their medical education. You can read the full article, “Virtual visits: Spurred on by the pandemic, telemedicine has gone mainstream,” here.

Is It Safe to Travel?

After months of isolation due to the COVID-19, many Las Vegas residents are eager for summer travels. While the lockdown restrictions have eased in Nevada and across the country, the risk of contracting COVID-19 remains. Roseman Medical Group’s Dr. Tom Hunt joined KSNV-TV Channel 3’s Heather Mills to discuss careful considerations and precautions you should take before booking your summer trip. You can see the whole story here.

Don’t Forget Routine Childhood Vaccinations

Routine vaccinations for children help keep families and communities healthy. During the COVID-19 pandemic many families have held off on or have been unable to get their children to their pediatrician. Roseman Medical Group’s Dr. Tom Hunt says that as a result, many are behind in the vaccinations, putting them at risk for severe and sometimes life-threatening diseases. Read more here about how it’s important to stay current with vaccinations even during the pandemic.